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Strong Hearts: A Remote, App-Enabled, Exercise Program for Patients With Congenital Heart Disease (Strong Hearts App)

NCT05853705 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2025-08-22

No results posted yet for this study

Summary

The overall goal of this program is to create a remote, mobile application enabled exercise program for patients with Congenital Heart Disease (CHD). Pilot trials will consist of a remote exercise program with app-embedded exercise modules designed to promote and encourage safe and healthy exercise habits across a range of CHD anatomies. This app-enabled program will allow for real time data collection integrating wearable devices, as well as compliance and safety monitoring to enhance research capabilities. The app-enabled program will be versatile and may be applied in the future to patients with non-cardiac conditions.

Conditions

  • Congenital Heart Disease

Interventions

BEHAVIORAL

Strong Hearts Exercise Program

The participant will either begin at the easiest variation of each strength exercise (level A), or will be placed at a specific level for each strength exercise based on their assessment with physical therapy. Participants can progress to the next level of difficulty of a specific strength exercise based on their rating of perceived exertion (RPE) with the opportunity to move to the next level if they have RPE score of 6 or less and if their heart rates are at goal. Each participant will be provided with heart rate ranges based on the heart rate reserve (HRR) method using their baseline resting and peak heart rates obtained during their cardiopulmonary exercise testing (CPET) or percent predicted heart rate based on age if CPET is not available. HRR goals will be set individually for patients and adjusted per protocol to guide effort.

Sponsors & Collaborators

  • Food and Drug Administration (FDA)

    collaborator FED

  • Duke University

    lead OTHER

Principal Investigators

  • Reid C Chamberlain, MD, MSCI · Duke UMC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
10 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-12
Primary Completion
2024-12-05
Completion
2024-12-05

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05853705 on ClinicalTrials.gov